DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-20 are pending and being examined.
Specification
The specification is objected to for:
the recitation of "XXXX" instead of a deposit number.
the Applicant describes “The seeds deposited with the NCMA on [date] were taken from the seed stock” (spec, p.58, para 0192, line 4). Instant description lacks the “date” when the said seeds are deposited.
Appropriate correction is required.
Claim Objections
Claims 1, 4 and 18-19 are objected to because they recite "XXXX" instead of an accession number.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 4 and 18-19 recite "5PSQU66" and "accession number XXXX". "5PSQU66" is an arbitrary name with no meaning sans a deposit number. "XXXX" is not an accession number, so it is unclear to what deposit the recitation refers.
All the claims directly or indirectly depending from claim 1 inherit the indefiniteness.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Enablement/Deposit
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims all require seed of Soybean variety: 5PSQU66. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public.
The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. So long as the number of seeds deposited complies with the requirements of the IDA where the deposit is made, the USPTO considers such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809.
It is noted that Applicant either deposited or intends to deposit seeds for soybean variety 5PSQU66 at the NCMA, but there is no indication that the seeds have already been deposited. Further, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made and accepted under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
If the deposit has not been made and accepted under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that-
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807).
In addition, the identifying information set forth in 37 CFR 1.809(d) should be added to the specification. See 37 CFR 1.801 - 1.809 [MPEP 2401-2411.05] for additional explanation of these requirements.
Written Description
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 16 depends from claim 15. Claim 16 is a product by process claim. A soybean plant produced by instant claim 15 would not have any apparent difference compared to a plant produced by a very different process using the same parents or different parent(s) but having the same or similar/comparable trait(s). In this case, the Applicant does not describe the gene(s) being edited and new traits being introduced.
An invention described solely in terms of a method of making and/or its function would lack written descriptive support where there is no described (in the specification) or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. See MPEP § 2163.
Considering the breadth of the claims, lack of representative species of the broad genus claimed, lack of structure function relationship of the broad genus claimed, the Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carden et al. (US20150250124 Al), Kalvig et al. (US 20230240232 A1) and Alt et al. (US 9474230 B1).
Carden et al. describes the XB19S14 soybean variety (abstract, line 1), which is one of the grandparents of instant variety 5PSQU66 (spec, p.59, para 1, line 5-7). Carden also describes several methods to produce a soybean plant by crossing soybean variety XB19S14 with another soybean plant via introgression into soybean variety XB19S14 (abstract, line 5-8). Soybean variety XB19S14 comprises only one herbicide resistance trait against glyphosate (p.18, Table 1). The “first line”, which is produced by crossing using XB19S14 variety as a parent (spec, p.59, para 1, line 5-7), comprises two herbicide resistance traits against two different herbicides- glyphosate and dicamba (a 2,4 D analog) (spec, p.59, para 1, line 11-14). Quantitative and qualitative traits including relative maturity (1.8), average yield (up to 58 bu/a) (p.19-20, Table 2), possession of phytophthora gene (1K), flower color (P), pubescence color (L), hila color (B), pod color (Brown) etc. of the elite soybean variety XB19S14 (p.18-19, Table 1) are either same or similar/comparable to the instant soybean variety 5PSQU66 (spec, p.59-60, Table 1).
However, Carden et al. does not describe the other parent (the “second propriety” variety) or the two grandparents comprising 5PRDB20 and 5PHQF75 that produced the second parent (the “second propriety” variety) of the instant variety 5PSQU66.
Kalvig et al. describes developing a soybean variety 5PSYM14 comprising herbicide resistance trait against three herbicides including glyphosate, glufosinate and 2,4 D (p.20, para 0246, Table 1) by using the soybean variety XB24AM14 which comprises only glyphosate resistance (as described in detail by Alt et al.; column, 36, Table 1) and 5PHQF75 (Kalvig et al.; p. 20, para 0246, line 6-8). The 5PHQF75 variety is also used as a trait donor to develop the “second property variety” used produce instant variety 5PSQU66 (spec, p.59, para 1, line 14-16). Thus, the trait donor variety 5PHQF75 donated the commercially important desired traits of herbicide resistance against three herbicides (glyphosate, glufosinate and 2,4 D) to the trait recipient variety 5PRDB20 to produce the “second propriety” soybean variety, as described by the Applicant (spec, p.59, para 1m line 14-22).
Before the effective filing date of the invention, it would have been obvious to one ordinarily skilled artisan and the artisan would have been motivated to combine (stacking) different and commercially useful traits of herbicide resistance against three different herbicides (glyphosate, glufosinate and dicamba/2,4D) coming from the “second propriety” variety which are introgressed from the trait donor variety 5PHQF75, to the elite soybean variety XB19S14 with several desired traits but having just one herbicide resistance trait against glyphosate (as described by Calvig et al.) or the “first propriety line” having resistance against two herbicides (glyphosate and dicamba, a 2,4 D analog) using methods that are well-known and routine in plant breeding. Using established elite varieties with a specific desired trait(s) to introgress the specific trait(s) in a target variety is also well-known and routine process in the art.
Conclusion
No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY CHATTERJEE whose telephone number is (703)756-1329. The examiner can normally be reached (Mon - Fri) 8.30 am to 5.30 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571) 270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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J.C.
/Jay Chatterjee/Examiner, Art Unit 1662
/BRATISLAV STANKOVIC/Supervisory Patent Examiner, Art Units 1661 & 1662
